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510(k) K173223

ologen Collagen Matrix by Aeon Astron Europe B.V. — Product Code KGN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 2018
Date Received
October 3, 2017
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wound Dressing With Animal-Derived Material(S)
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Other clearances by Aeon Astron Europe B.V.

  • K112568 — AONGEN DENTAL COLLAGEN MATRIX (March 1, 2012)
  • K080868 — AONGEN COLLAGEN MATRIX (May 14, 2009)

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  • K242100 — SurgiAid Collagen Wound Dressing (HA) (October 16, 2025)
  • K252001 — Collagen Wound Dressing (October 10, 2025)
  • K250397 — Helios Dermal Scaffold (August 15, 2025)
  • K251845 — Marigen Wound Extra; Kerecis Silicone; Kerecis Parvus (July 16, 2025)